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出境医 / 临床实验 / 测量和评估重复牙科治疗儿童焦虑水平的变化
测量和评估重复牙科治疗儿童焦虑水平的变化
Study Description
Brief Summary:
Dental anxiety is defined as the fear of terrible events during dental treatment and the loss of control.Anxiety may be related to adaptation of the patient to external factors in environment, so the adaptation of the pediatric patient to the stimuli in the dental environment may affect the level of anxiety.The aim of the this study was to evaluate the relationship between sequential visits in dental treatments and dental anxiety levels of pediatric patients with anxiety scales and physiological measurements.
| Condition or disease | Intervention/treatment |
|---|---|
| Dental Anxiety | Procedure: Dental treatment |
Detailed Description:
A total of 224 children aged 5-8 years who needed at least two restorative dental treatment of the mandibular first primary molar were included in the study.
In each sessions the Wong-Baker FACES Pain Rating Scale (W-BFRS) was used to evaluate the dental anxiety before and after the treatment.
The Modified Corah's Dental Anxiety Scale (MDAS) was used as a dental anxiety measurement method.
A portable finger pulse oximeter (Nellcor™ PMN10, Medtronic Corp. MN, USA) was used to measure the heart rate.
Data were statistically analyzed with the help of the Statistical Package for Social Sciences statistical software (SPSS 18.0), considering a 5% significance level. Nonparametric tests were used. Normality assumption was evaluated with the Kolmogorov Smirnov test. The association between two groups was analyzed by Wilcoxon Signed Rank Test.
Study Design
| Study Type : | Observational |
| Actual Enrollment : | 224 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | Measuring and Evaluating the Changes in Anxiety Levels of Children With Repetitive Sessions of Dental Treatments: A Retrospective Observational Cohort Study |
| Actual Study Start Date : | March 1, 2020 |
| Actual Primary Completion Date : | July 30, 2020 |
| Actual Study Completion Date : | August 30, 2020 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
First Visit
Children who visit dentist at first time
|
Procedure: Dental treatment
bilateral restorative treatment on the mandibular primary first molars
|
|
Second Visit
Children who visit dentist at second time
|
Procedure: Dental treatment
bilateral restorative treatment on the mandibular primary first molars
|
Outcome Measures
Primary Outcome Measures :
- Dental anxiety [ Time Frame: at the first dental visit, during two weeks ]The Modified Corah's Dental Anxiety Scale minimum 5 points maximum 25 points more than 15 points means patient have dental axiety .Higher points mean worse outcome
- Dental anxiety [ Time Frame: at the second dental visit, during two weeks ]The Modified Corah's Dental Anxiety Scale minimum 5 points maximum 25 points more than 15 points means patient have dental axiety .Higher points mean worse outcome
Eligibility Criteria
| Ages Eligible for Study: | 5 Years to 8 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
A total of 224 children aged 5-8 years who needed at least two restorative dental treatments of the mandibular first primary molar were included in the study. As the inclusion criteria, children with no mental disorders, with no past dental experience, hospitalization or invasive medical treatments, and no pain or symptom in their oral health. All included children and parents had to spoken and understood the Turkish language. Patients with chronic systemic illnesses that may affect the blood pressure or heart rate of a child were excluded from the study. Only children who required multiple-visit treatments were taken into consideration.
Criteria
Inclusion Criteria:
- Children aged 5-8 years
- Children who need at least two restorative dental treatments of the mandibular first primary molar
Exclusion Criteria:
- Chronic systemic illnesses
- Dental experience
- Mental disorders
- Invasive medical treatments
- Hospitalization
- Oral health problems with a painful history
Contacts and Locations
Locations
| Turkey | |
| Nurcan Kutluer Karaca | |
| Erzincan, Turkey | |
Sponsors and Collaborators
Erzincan University
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | June 8, 2021 | ||||
| First Posted Date | July 19, 2021 | ||||
| Last Update Posted Date | July 19, 2021 | ||||
| Actual Study Start Date | March 1, 2020 | ||||
| Actual Primary Completion Date | July 30, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Measuring and Evaluating the Changes in Anxiety Levels of Children With Repetitive Sessions of Dental Treatments | ||||
| Official Title | Measuring and Evaluating the Changes in Anxiety Levels of Children With Repetitive Sessions of Dental Treatments: A Retrospective Observational Cohort Study | ||||
| Brief Summary | Dental anxiety is defined as the fear of terrible events during dental treatment and the loss of control.Anxiety may be related to adaptation of the patient to external factors in environment, so the adaptation of the pediatric patient to the stimuli in the dental environment may affect the level of anxiety.The aim of the this study was to evaluate the relationship between sequential visits in dental treatments and dental anxiety levels of pediatric patients with anxiety scales and physiological measurements. | ||||
| Detailed Description |
A total of 224 children aged 5-8 years who needed at least two restorative dental treatment of the mandibular first primary molar were included in the study. In each sessions the Wong-Baker FACES Pain Rating Scale (W-BFRS) was used to evaluate the dental anxiety before and after the treatment. The Modified Corah's Dental Anxiety Scale (MDAS) was used as a dental anxiety measurement method. A portable finger pulse oximeter (Nellcor™ PMN10, Medtronic Corp. MN, USA) was used to measure the heart rate. Data were statistically analyzed with the help of the Statistical Package for Social Sciences statistical software (SPSS 18.0), considering a 5% significance level. Nonparametric tests were used. Normality assumption was evaluated with the Kolmogorov Smirnov test. The association between two groups was analyzed by Wilcoxon Signed Rank Test. |
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| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | A total of 224 children aged 5-8 years who needed at least two restorative dental treatments of the mandibular first primary molar were included in the study. As the inclusion criteria, children with no mental disorders, with no past dental experience, hospitalization or invasive medical treatments, and no pain or symptom in their oral health. All included children and parents had to spoken and understood the Turkish language. Patients with chronic systemic illnesses that may affect the blood pressure or heart rate of a child were excluded from the study. Only children who required multiple-visit treatments were taken into consideration. | ||||
| Condition | Dental Anxiety | ||||
| Intervention | Procedure: Dental treatment
bilateral restorative treatment on the mandibular primary first molars
|
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| Study Groups/Cohorts |
|
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
224 | ||||
| Original Actual Enrollment | Same as current | ||||
| Actual Study Completion Date | August 30, 2020 | ||||
| Actual Primary Completion Date | July 30, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | 5 Years to 8 Years (Child) | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Turkey | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT04967300 | ||||
| Other Study ID Numbers | Erzincan Binali Yıldırım U. | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement |
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| Responsible Party | Nurcan Kutluer Karaca, Erzincan University | ||||
| Study Sponsor | Erzincan University | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Erzincan University | ||||
| Verification Date | July 2021 | ||||